Spinal implant system and methods of use

ABSTRACT

A method comprises the steps of: imaging a patient anatomy; selecting an implant strategy for at least one bone fastener having a first member; registering the imaging of the patient anatomy with imaging of at least a portion of a robot; engaging the first member with tissue of the patient anatomy via robotic guidance according to the implant strategy; and subsequently, manipulating the patient anatomy. Systems, spinal constructs, implants and surgical instruments are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system and method for treating a spine.

BACKGROUND

Spinal disorders such as degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvatureabnormalities, kyphosis, tumor, and fracture may result from factorsincluding trauma, disease and degenerative conditions caused by injuryand aging. Spinal disorders typically result in symptoms including pain,nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. As part of these surgical treatments, interbodydevices can be employed with spinal constructs, which include implantssuch as bone fasteners and vertebral rods to provide stability to atreated region. These implants can redirect stresses away from a damagedor defective region while healing takes place to restore properalignment and generally support the vertebral members. During surgicaltreatment, one or more rods and bone fasteners can be delivered to asurgical site. Surgical instruments are employed, for example, to engagethe fasteners for attachment to the exterior of two or more vertebralmembers. This disclosure describes an improvement over these priortechnologies.

SUMMARY

In one embodiment, a method for treating a spine is provided. The methodcomprises the steps of: imaging a patient anatomy; selecting an implantstrategy for at least one bone fastener having a first member;registering the imaging of the patient anatomy with imaging of at leasta portion of a robot; engaging the first member with tissue of thepatient anatomy via robotic guidance according to the implant strategy;and subsequently, manipulating the patient anatomy. In some embodiments,systems, spinal constructs, implants and surgical instruments aredisclosed.

In one embodiment, the method comprises the steps of: pre-operativelygenerating a CT scan of a patient anatomy including at least onevertebra; selecting an implant strategy according to the CT scan for atleast one bone screw shaft; generating fluoroscopic images of at least aportion of a robot; registering the CT scan with the fluoroscopicimages; engaging the bone screw shaft with the vertebra via roboticguidance according to the implant strategy; subsequently, manipulatingthe patient anatomy; and manually engaging an implant receiver with thebone screw shaft to comprise a bone screw.

In one embodiment, the method comprises the steps of: imaging vertebraltissue; selecting an implant strategy for at least one bone screw shaft;registering the imaging of the vertebral tissue with imaging of a robotconnected with the vertebral tissue; connecting a surgical driver withthe bone screw shaft, the surgical driver including an image guideoriented relative to a sensor to communicate a signal representative ofa position of the bone screw shaft; engaging the bone screw shaft withthe vertebral tissue via robotic guidance according to the implantstrategy; subsequently, manipulating the vertebral tissue; and manuallyengaging an implant receiver with the bone screw shaft to comprise abone screw.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a plan view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 2 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 3 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 4 is a break away view of the components shown in FIG. 3;

FIG. 5 is a side, cross section view of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 6 is a side view of the components shown in FIG. 5;

FIG. 7 is a side view of the components shown in FIG. 5;

FIG. 8 is a side view of the components shown in FIG. 5;

FIG. 9 is a side view of the components shown in FIG. 5;

FIGS. 10A and 10B are flow diagrams illustrating representative steps ofembodiments of a method and a surgical system in accordance with theprinciples of the present disclosure;

FIG. 10C is a plan view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 11 is a graphical representation of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 12 is a graphical representation of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 13 is a plan view of one embodiment of an implant strategy inaccordance with the principles of the present disclosure;

FIG. 14 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 15 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 16 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae; and

FIG. 17 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae.

DETAILED DESCRIPTION

The exemplary embodiments of a surgical system are discussed in terms ofmedical devices for the treatment of musculoskeletal disorders and moreparticularly, in terms of a surgical system and a method for treating aspine. In some embodiments, the present surgical system comprises animage guided, robot assisted spinal implant system. In some embodiments,the present surgical system comprises a robotic guidance system and aselectively coupled bone screw system that allows for operating roomassembly of a bone fastener. In some embodiments, the systems andmethods of the present disclosure comprise surgical robotic guidance,surgical navigation and medical devices including surgical instrumentsand implants that are employed with a surgical treatment, as describedherein, for example, with a cervical, thoracic, lumbar and/or sacralregion of a spine.

In some embodiments, the present surgical system is employed with amethod of performing robotically-assisted spinal surgery. In someembodiments, the method includes the step of delivering posterior spinalinstrumentation through robotic-assisted trajectory alignment tools. Insome embodiments, the present surgical system and method includessurgical robotic guidance having robotic software that performsregistration of a patient anatomy to a three dimensional working spaceof a robot.

In some embodiments, the present surgical system is employed with amethod of performing robotically-assisted spinal surgery including thestep of generating a pre-operative CT scan that is used to pre-planlocations of pedicle screws for implant in an operating room. In someembodiments, during surgery, the method includes the step ofidentification of the same patient anatomy as recorded on thepre-operative CT scan. In some embodiments, the patient anatomy isaccurately identified and located in the robot's three dimensionalcoordinate system to proceed with a selected procedure. In someembodiments, registration and placement of the pedicle screws isperformed prior to spinal manipulation including decompression, discpreparation and/or interbody insertion, to avoid alteration of apatient's anatomy, for example, vertebral bones. Such alteration canprevent the robotic software from identifying common landmarks during anintra-operative registration process. In some embodiments, the presentsystem and method avoid interference from implant receivers implantedprior to spinal manipulation.

In some embodiments, the present surgical system is employed with amethod of performing robotically-assisted spinal surgery including thestep of inserting screws that only have a shank-portion of a screwassembly when using robotic guidance. In some embodiments, after thescrew shanks are placed under robotic guidance, decompression, discpreparation and/or interbody insertion can be performed withoutinterference; for example, such interference can occur from screws withimplant receivers implanted prior to spinal manipulation, which caninterfere with access to a surgical site. In some embodiments, afterdecompression, disc preparation and/or interbody insertion, implantreceivers, for example, modular implant receivers or screw heads may beattached to the screw shanks. In some embodiments, this configuration ofthe modular screw provides a screw shank having a smaller head/shaftdiameter of an unassembled construct, relative to an assembled screwhaving an implant receiver, which uses robotic guidance for spinalfusion surgery.

In some embodiments, the present surgical system is employed with amethod that includes the steps of placing a spinal construct havingscrew-shanks, for example, headless screws that will have modular headsattached thereafter and employed with a robotically-assisted trajectorysystem. In some embodiments, the present surgical system is employedwith a method that includes the steps of registering a robot, placingscrew shanks using a robotic trajectory guidance, performingdecompression and disc removal, inserting interbody devices withvertebrae, connecting screw heads to the screw shanks, inserting spinalrods with the screw heads and securing the spinal construct with thevertebrae.

In some embodiments, the present surgical system comprises a driverconfigured for use with a modular screw platform. In some embodiments,the driver is configured for engagement with a screw shank, without atulip head attached. In some embodiments, the driver includes a colletand a sleeve. In some embodiments, the sleeve is sized to grasp aspherical head of the screw shank. In some embodiments, the surgicalsystem is utilized with a method including the step of disposing adriver in an initial open configuration by translating the sleeve out ofengagement with the collet allowing the collet to expand for disposal ofthe screw shank. In some embodiments, the method includes the step ofinserting the screw shank into the collet. In some embodiments, themethod includes the step of engaging the screw shank with tissue. Insome embodiments, the method includes the step of translating the sleeveout of engagement with the collet to release the screw shank. In someembodiments, the surgical instrument comprises a driver configured to beutilized with multiple design requirements of a modular screw platform.In some embodiments, the surgical instrument includes a driverconfigured to drive a bone screw shank without a tulip head attachedthereto.

In some embodiments, the present surgical system comprises a modularsystem having a bone fastener including an array of members, such as,for example, receivers that can be selectively coupled to members, suchas, for example, bone screw shafts. In some embodiments, the presentsurgical system comprises a selectively coupled bone fastener that canbe assembled on a surgical table or in-situ. In some embodiments, theselectively coupled bone fastener is assembled with a force of less than50 Newtons (N). In some embodiments, the bone fastener is selectivelycoupled with a non-instrumented assembly. In some embodiments, thenon-instrumented assembly comprises manually engaging a screw shaft witha head/receiver of the bone fastener. In some embodiments, thenon-instrumented assembly comprises manually engaging the screw shaft ina pop-on engagement with the head/receiver of the bone fastener. In someembodiments, a force required to manually engage a screw shaft with ahead/receiver of the bone fastener in a non-instrumented assembly is ina range of 2 to 50 N. In some embodiments, a force required to manuallyengage a screw shaft with a head/receiver of the bone fastener in anon-instrumented assembly is in a range of 5 to 10 N. In someembodiments, a screw shaft is manually engaged with a head/receiver ofthe bone fastener in a non-instrumented assembly, as described herein,such that removal of the head/receiver from the screw shaft requires aforce and/or a pull-out strength of at least 5000 N. In someembodiments, this configuration provides manually engageable componentsof a bone fastener that are assembled without instrumentation, andsubsequent to assembly, the assembled components have a selectedpull-out strength and/or can be pulled apart, removed and/or separatedwith a minimum required force.

In some embodiments, the bone fastener includes a ring disposed with areceiver connectable with a screw shaft. In some embodiments, the ringis configured to snap onto the screw shaft. In some embodiments, thering has a minimized thickness and/or height to facilitate snapping thering onto the screw shaft. In some embodiments, the force required tosnap the ring onto the screw shaft is in a range of 2 to 50 N. In someembodiments, the force required to snap the ring onto the screw shaft isin a range of 5 to 10 N.

In some embodiments, the bone fastener is configured for assemblywithout the use of an instrument, such as, for example, a practitioner,surgeon and/or medical staff utilizes their hands for assembly. In someembodiments, the system requires minimal force to attach a receiver anda shaft in-situ thereby reducing a pre-load on the vertebrae, such as,for, example, the pedicle. In some embodiments, the bone fastenerincludes a receiver having a double ring chamber. In some embodiments,the bone fastener includes an expandable ring. In some embodiments, thebone fastener is configured for assembly with the use of an instrument.

In some embodiments, the bone fastener includes an implant receiver thatis rotatable and/or pivotable relative to a screw shaft in a selectedrange of movement configuration, for example, a multi-axial screw (MAS),a uni-axial screw (UAS), a fixed angle screw (FAS), a sagittal adjustingscrew (SAS) or a transverse sagittal adjusting screw (TSAS). In someembodiments, the bone fastener can include one or more multi-axialscrews, sagittal angulation screws, pedicle screws, mono-axial screws,uni-planar screws, facet screws, fixed screws, tissue penetratingscrews, conventional screws, expanding screws, wedges, anchors, buttons,clips, snaps, friction fittings, compressive fittings, expanding rivets,staples, nails, adhesives, fixation plates and/or posts.

In some embodiments, the system of the present disclosure may beemployed to treat spinal disorders such as, for example, degenerativedisc disease, disc herniation, osteoporosis, spondylolisthesis,stenosis, scoliosis and other curvature abnormalities, kyphosis, tumorand fractures. In some embodiments, the system of the present disclosuremay be employed with other osteal and bone related applications,including those associated with diagnostics and therapeutics. In someembodiments, the disclosed system may be alternatively employed in asurgical treatment with a patient in a prone or supine position, and/oremploy various surgical approaches to the spine, including anterior,posterior, posterior mid-line, direct lateral, postero-lateral, and/orantero-lateral approaches, and in other body regions. The system of thepresent disclosure may also be alternatively employed with proceduresfor treating the lumbar, cervical, thoracic, sacral and pelvic regionsof a spinal column. The system of the present disclosure may also beused on animals, bone models and other non-living substrates, such as,for example, in training, testing and demonstration.

The system of the present disclosure may be understood more readily byreference to the following detailed description of the embodiments takenin connection with the accompanying drawing figures, which form a partof this disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. In some embodiments, as used inthe specification and including the appended claims, the singular forms“a,” “an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. Also, as used in the specificationand including the appended claims, the term “tissue” includes softtissue, ligaments, tendons, cartilage and/or bone unless specificallyreferred to otherwise.

The following discussion includes a description of a surgical systemincluding surgical robotic guidance, surgical navigation, surgicalinstruments, spinal constructs, implants, related components and methodsof employing the surgical system in accordance with the principles ofthe present disclosure. Alternate embodiments are also disclosed.Reference is made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningto FIGS. 1-4, there are illustrated components of a surgical system,such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, aluminum, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL®), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 can be employed, for example, with a minimallyinvasive procedure, including percutaneous techniques, mini-open andopen surgical techniques to manipulate tissue, deliver and introduceinstrumentation and/or components of spinal constructs at a surgicalsite within a body of a patient, for example, a section of a spine. Insome embodiments, one or more of the components of surgical system 10are configured for engagement with existing spinal constructs, which mayinclude spinal implants such as one or more rods, fasteners, plates andconnectors. In some embodiments, the spinal constructs can be attachedwith vertebrae in a revision surgery to manipulate tissue and/or correcta spinal disorder, as described herein.

Spinal implant system 10, as described herein, includes a surgicalrobotic guidance system 12 having a robotic arm 14, which is employedwith a surgical navigation system 16 and one or a plurality of surgicalinstruments for manipulating vertebral tissue, and for delivering andintroducing components of spinal constructs for engagement with thevertebral tissue. For example, a surgical driver 18 can be employed withan end effector 20 of robotic arm 14 to facilitate implant with roboticarm 14. Driver 18 is guided through end effector 20 for guide-wirelessinsertion of a spinal implant, such as, for example, a screw shaft 22 ofa bone fastener 24.

Screw shaft 22 includes an interchangeable mating element, such as, forexample, a head 26 that is interchangeable with a mating element, asdescribed herein, of a receiver 28 to form a selected bone fastener 24having a selected movement of its components parts and/or movementrelative to vertebral tissue. In some embodiments, the selected movementincludes rotation and/or pivotal movement of shaft 22 relative toreceiver 28 about one or a plurality of axes. In some embodiments, theselected movement includes rotation and/or pivotal movement of shaft 22relative to receiver 28 through one or a plurality of planes. In someembodiments, shaft 22 is connected to a selected receiver 28 to comprisea MAS, UAS, FAS, SAS or TSAS. In some embodiments, spinal implant system10 comprises a spinal implant kit, which includes receivers 28 andalternate receivers, such as those described herein. A selected receiver28 is configured for selection from the kit of receivers 28 such thatthe selected receiver 28 is connectable with an interchangeable shaft22. In some embodiments, a selected receiver 28 is configured forselection from the kit of receivers 28 such that receiver 28 isconnectable with a compatible shaft 22.

Shaft 22 has a cylindrical cross-sectional configuration and includes anouter surface having an external thread form. In some embodiments, theexternal thread form may include a single thread or a plurality ofdiscrete threads. In some embodiments, other engaging structures may belocated on shaft 22, such as, for example, a nail configuration, barbs,expanding elements, raised elements and/or spikes to facilitateengagement of shaft 22 with tissue. In some embodiments, all or only aportion of shaft 22 may have alternate cross section configurations,such as, for example, oval, oblong, triangular, square, polygonal,irregular, uniform, non-uniform, offset, staggered, undulating, arcuate,variable and/or tapered. In some embodiments, the outer surface of shaft22 may include one or a plurality of openings. In some embodiments, allor only a portion of the outer surface of shaft 22 may have alternatesurface configurations to enhance fixation with tissue, such as, forexample, rough, arcuate, undulating, mesh, porous, semi-porous, dimpledand/or textured. In some embodiments, all or only a portion of shaft 22may be disposed at alternate orientations, relative to its longitudinalaxis, such as, for example, transverse, perpendicular and/or otherangular orientations such as acute or obtuse, co-axial and/or may beoffset or staggered. In some embodiments, all or only a portion of shaft22 may be cannulated.

Head 26 defines a drive interface, such as, for example, a socket 30.Socket 30 is configured for a mating engagement with driver 18 anddefines a hexalobe configuration. Driver 18 includes an inner drive 32engageable with socket 30 of head 26 and an outer sleeve 34 to disposedriver 18 in a capture orientation of screw shaft 22. In someembodiments, sleeve 34/drive 32 define a cavity configured for disposalof head 26 and sleeve 34 includes an expandable collet to capture shaft22. In some embodiments, sleeve 34/drive 32 define a cavity configuredfor disposal of head 26 and sleeve 34 includes a threaded portion (notshown) configured for engagement with a portion of head 26 to pulland/or draw shaft 22 axially into the cavity and into engagement withdrive 32 to capture shaft 22.

For example, in use, driver 18 is disposed in an open orientation, suchthat drive 32 extends from driver 18, as shown in FIG. 16. Drive 32 isaligned with socket 30 and engaged with head 26. Sleeve 34 is rotatedrelative to drive 32 in a clockwise direction, as shown by arrow A inFIG. 16, such that internal threaded surfaces (not shown) cause sleeve34 to axially translate, as shown by arrow B in FIG. 16, relative todrive 32 to capture shaft 22 with drive 32. Upon connection and captureof shaft 22, driver 18 is rotated in a clockwise direction, as shown byarrow A in FIG. 16, such that driver 18 is engaged with shaft 22 tomanipulate, fasten, drive, torque or insert shaft 22 with tissue,similar to that described herein. To release driver 18 from shaft 22,sleeve 34 is rotated relative to drive 32, in a counter-clockwisedirection, as shown by arrow C in FIG. 17, such that sleeve 34 axiallytranslates relative to drive 32 to release head 26 from drive 32. Driver18 is disengageable from shaft 22.

In some embodiments, upon disposal of shaft 22 with vertebral tissue, asdescribed herein, receiver 28 includes a mating surface 40 configured tointerface in a selective mating engagement with head 26. In someembodiments, mating surface 40 includes flats and/or arcuate surfaces toform various bone screw configurations, such as those described herein.Head 26 is slidably engageable with surface 40 and movable relativethereto such that shaft 22 is rotatable along a plurality of axesrelative to receiver 28 including rotation about axis X1. As such,interchangeable shaft 22 is connected with a selected receiver 28 fromthe kit of receivers 28 to form a bone fastener 24.

Receiver 28 defines a groove 42 configured for disposal of acircumferential ring 44, as shown in FIGS. 5-9. Groove 42 includes acircumferential channel 46 having a diameter d1 and a circumferentialchannel 48 having a diameter d2 that is greater than diameter d1.Channel 48 is adjacent and proximal to channel 46. Channel 48 isseparated from channel 46 by a lip 50. In some embodiments, shaft 22 ismanually engageable with receiver 28 and/or shaft 22 is coupled withreceiver 28 in a non-instrumented assembly such that ring 44 translatesfrom and into channels 46, 48, and over lip 50, as described herein.Ring 44 is expandable and resilient between a contracted and/or captureorientation, and an expanded orientation, as described herein. Ring 44facilitates manual engagement of a selected receiver 28 and shaft 22such that the selected receiver 28 is attached with shaft 22 in anon-instrumented assembly, as described herein.

In some embodiments, manual engagement and/or non-instrumented assemblyof receiver 28 and shaft 22 includes the coupling of receiver 28 andshaft 22 without use of separate and/or independent instrumentationengaged with bone fastener 24 components to effect assembly. In someembodiments, manual engagement and/or non-instrumented assembly includesa practitioner, surgeon and/or medical staff grasping receiver 28 andshaft 22 and forcibly assembling the components of bone fastener 24. Insome embodiments, manual engagement and/or non-instrumented assemblyincludes a practitioner, surgeon and/or medical staff grasping receiver28 and shaft 22 and forcibly snap fitting the components of bonefastener 24 together, as described herein. In some embodiments, manualengagement and/or non-instrumented assembly includes a practitioner,surgeon and/or medical staff grasping receiver 28 and shaft 22 andforcibly pop fitting the components of bone fastener 24 together and/orpop fitting receiver 28 onto shaft 22, as described herein. In someembodiments, a force in a range of 2-50 N is required to manually engagereceiver 28 and shaft 22 and forcibly assemble the components of bonefastener 24. For example, a force in a range of 2-50 N is required tosnap fit and/or pop fit assemble receiver 28 and shaft 22. In someembodiments, a force in a range of 5-10 N is required to manually engagereceiver 28 and shaft 22 and forcibly assemble the components of bonefastener 24. For example, a force in a range of 5-10 N is required tosnap fit and/or pop fit assemble receiver 28 and shaft 22. In someembodiments, shaft 22 is manually engaged with receiver 28 in anon-instrumented assembly, as described herein, such that removal ofreceiver 28 from shaft 22 requires a force and/or a pull-out strength ofat least 5000 N. In some embodiments, this configuration providesmanually engageable components of bone fastener 24 that are assembledwithout instrumentation, and subsequent to assembly, the assembledcomponents have a selected pull-out strength and/or can be pulled apart,removed and/or separated with a minimum required force. In someembodiments, bone fastener 24 is configured for assembly with the use ofan instrument.

Receiver 28 includes a slot 52 configured to receive a flange of a crown54. Crown 54 is configured for disposal within an implant cavity 56 ofreceiver 28 and disposal of a spinal rod (not shown). Head 26 isinterchangeably engageable with any of the plurality of receivers 28.Head 26 includes a substantially spherical proximal portion configuredfor moveable disposal with the selected receiver 28 and crown 54. Head26 includes a plurality of ridges to improve purchase with crown 54.Head 26 has a maximum diameter d3 and applies a force to ring 44 to movering 44 between a contracted and/or capture orientation and an expandedorientation, as described herein. In some embodiments, head 26 includesinterchangeable mating surfaces, such as for example, arcuate portionsand/or planar portions configured for disposal with receiver 28 to limitrotation of receiver 28 relative to shaft 22. In some embodiments,receiver 28 may be disposed with shaft 22 in alternate fixationconfigurations, such as, for example, friction fit, pressure fit,locking protrusion/recess, locking keyway and/or adhesive.

Receiver 28 extends along and defines an axis X1, as shown in FIG. 9.Receiver 28 includes a pair of spaced apart arms that define implantcavity 56 therebetween configured for disposal of a component of aspinal construct, such as, for example, a spinal rod (not shown). Thearms of receiver 28 each extend parallel to axis X1. In someembodiments, the arms may be disposed at alternate orientations,relative to axis X1, such as, for example, transverse, perpendicularand/or other angular orientations such as acute or obtuse, coaxialand/or may be offset or staggered. The arms of receiver 28 each includean arcuate outer surface extending between a pair of side surfaces. Atleast one of the outer surfaces and the side surfaces of the arms ofreceiver 28 have at least one recess or cavity therein configured toreceive an insertion tool, compression instrument and/or instruments forinserting and tensioning bone fastener 24. In some embodiments, the armsof receiver 28 are connected at proximal and distal ends thereof suchthat receiver 28 defines a closed spinal rod slot.

Cavity 56 is substantially U-shaped. In some embodiments, all or only aportion of cavity 56 may have alternate cross section configurations,such as, for example, closed, V-shaped, W-shaped, oval, oblongtriangular, square, polygonal, irregular, uniform, non-uniform, offset,staggered, and/or tapered. Receiver 28 includes an inner surface havingthread forms configured for engagement with a coupling member, such as,for example, a setscrew (not shown), to retain a spinal construct, suchas, for example, a spinal rod (not shown) within cavity 56. In someembodiments, receiver 28 may be disposed with the coupling member inalternate fixation configurations, such as, for example, friction fit,pressure fit, locking protrusion/recess, locking keyway and/or adhesive.In some embodiments, receiver 28 may include alternate configurations,such as, for example, closed, open and/or side access.

In some embodiments, driver 18 includes a navigation component 58, asshown in FIG. 2. Driver 18 is configured for disposal adjacent asurgical site such that navigation component 58 is oriented relative toa sensor array 60, as shown in FIG. 1, to facilitate communicationbetween navigation component 58 and sensor array 60 during a surgicalprocedure, as described herein. Navigation component 58 is configured togenerate a signal representative of a position of screw shaft 22relative to driver 18 and/or tissue. In some embodiments, the imageguide may include human readable visual indicia, human readable tactileindicia, human readable audible indicia, one or more components havingmarkers for identification under x-ray, fluoroscopy, CT or other imagingtechniques, at least one light emitting diode, a wireless component, awired component, a near field communication component and/or one or morecomponents that generate acoustic signals, magnetic signals,electromagnetic signals and/or radiologic signals. In some embodiments,navigation component 58 is connected with driver 18 via an integralconnection, friction fit, pressure fit, interlocking engagement, matingengagement, dovetail connection, clips, barbs, tongue in groove,threaded, magnetic, key/keyslot and/or drill chuck.

Navigation component 58 includes an emitter array 62. Emitter array 62is configured for generating a signal to sensor array 60 of surgicalnavigation system 16. In some embodiments, the signal generated byemitter array 62 represents a position of screw shaft 22 relative todriver 18 and relative to tissue, such as, for example, bone. In someembodiments, the signal generated by emitter array 62 represents athree-dimensional position of screw shaft 22 relative to tissue. In someembodiments, emitter array 62 may include a reflector array configuredto reflect a signal from sensor array 60.

In some embodiments, sensor array 60 receives signals from emitter array62 to provide a three-dimensional spatial position and/or a trajectoryof screw shaft 22 relative to driver 18 and/or tissue. Emitter array 62communicates with a processor of a computer 64 of navigation system 16to generate data for display of an image on a monitor 66, as describedherein. In some embodiments, sensor array 60 receives signals fromemitter array 62 to provide a visual representation of a position ofscrew shaft 22 relative to driver 18 and/or tissue. See, for example,similar surgical navigation components and their use as described inU.S. Pat. Nos. 6,021,343, 6,725,080, 6,796,988, the entire contents ofeach of these references being incorporated by reference herein.

Surgical navigation system 16 is configured for acquiring and displayingmedical imaging, such as, for example, x-ray images appropriate for agiven surgical procedure. In some embodiments, pre-acquired images of apatient are collected. In some embodiments, surgical navigation system16 can include an O-arm® imaging device 68 sold by Medtronic Navigation,Inc. having a place of business in Louisville, Colo., USA. Imagingdevice 68 may have a generally annular gantry housing that encloses animage capturing portion 70.

In some embodiments, navigation system 16 comprises image capturingportion 70 that may include an x-ray source or emission portion and anx-ray receiving or image receiving portion located generally or aspractically possible 180 degrees from each other and mounted on a rotor(not shown) relative to a track of image capturing portion 70. Imagecapturing portion 70 can be operable to rotate 360 degrees during imageacquisition. Image capturing portion 70 may rotate around a centralpoint or axis, allowing image data of the patient to be acquired frommultiple directions or in multiple planes. Surgical navigation system 16can include those disclosed in U.S. Pat. Nos.8,842,893, 7,188,998;7,108,421; 7,106,825; 7,001,045; and 6,940,941; the entire contents ofeach of these references being incorporated by reference herein.

In some embodiments, surgical navigation system 16 can include C-armfluoroscopic imaging systems, which can generate three-dimensional viewsof a patient. The position of image capturing portion 70 can beprecisely known relative to any other portion of an imaging device ofnavigation system 16. In some embodiments, a precise knowledge of theposition of image capturing portion 70 can be used in conjunction with atracking system 72 to determine the position of image capturing portion70 and the image data relative to the patient.

Tracking system 72 can include various portions that are associated orincluded with surgical navigation system 16. In some embodiments,tracking system 72 can also include a plurality of types of trackingsystems, such as, for example, an optical tracking system that includesan optical localizer, such as, for example, sensor array 60 and/or an EMtracking system that can include an EM localizer. Various trackingdevices can be tracked with tracking system 72 and the information canbe used by surgical navigation system 16 to allow for a display of aposition of an item, such as, for example, a patient tracking device, animaging device tracking device 74, and an instrument tracking device,such as, for example, emitter array 62, to allow selected portions to betracked relative to one another with the appropriate tracking system.

In some embodiments, the EM tracking system can include theSTEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation,Inc. having a place of business in Louisville, Colo. Exemplary trackingsystems are also disclosed in U.S. Patent Nos. 8,057,407, 5,913,820,5,592,939, the entire contents of each of these references beingincorporated by reference herein.

Fluoroscopic images taken are transmitted to computer 64 where they maybe forwarded to a computer 76. Image transfer may be performed over astandard video connection or a digital link including wired andwireless. Computer 76 provides the ability to display, via monitor 66,as well as save, digitally manipulate, or print a hard copy of thereceived images. In some embodiments, images may also be displayed tothe surgeon through a heads-up display.

In some embodiments, surgical navigation system 16 provides forreal-time tracking of the position of screw shaft 22 relative to driver18 and/or tissue can be tracked. Sensor array 60 is located in such amanner to provide a clear line of sight with emitter array 62, asdescribed herein. In some embodiments, fiducial markers 80 of emitterarray 62 communicate with sensor array 60 via infrared technology.Sensor array 60 is coupled to computer 64, which may be programmed withsoftware modules that analyze signals transmitted by sensor array 60 todetermine the position of each object in a detector space.

Driver 18 is configured for use with end effector 20. End effector 20includes a surface 82 that defines a channel 84. Channel 84 isconfigured for passage of the components of bone fastener 24 anddisposal of driver 18, and/or spinal construct components and surgicalinstruments, as described herein. Robotic arm 14 includes positionsensors (not shown), similar to those referenced herein, which measure,sample, capture and/or identify positional data points of end effector20 in three dimensional space for a guide-wireless insertion ofcomponents of bone fasteners 24, for example, screw shafts 22 withselected vertebral levels. In some embodiments, surface 82 comprises anaxial trajectory guide configured for passage of the components of bonefastener 24 and disposal of driver 18, and/or spinal constructcomponents and surgical instruments, as described herein. In someembodiments, a sleeve, which comprises an axial trajectory guide, isconnected with surface 82. In some embodiments, the position sensors ofrobotic arm 14 are employed in connection with surgical navigationsystem 16 to measure, sample, capture and/or identify positional datapoints of end effector 20 in connection with surgical treatment, asdescribed herein. The position sensors are mounted with robotic arm 14and calibrated to measure positional data points of end effector 20 inthree dimensional space, which are communicated to the components ofsurgical robotic guidance system 12 and/or computer 64. See, forexample, the surgical robotic guidance systems and methods described inU.S. Pat. No. 8,571,638, the contents of which being hereby incorporatedby reference herein in its entirety.

Surgical robotic guidance system 12 includes a surgical robot 86including robotic arm 14, which positions one or more surgicalinstruments, as described herein, with respect to a surgical site and isemployed with a method for using robot 86 to assist in surgicalprocedures. In some embodiments, robot 86 attaches to patient anatomy,for example, bone with a clamp (not shown) or K-wires of robot 86.Robotic arm 14 extends and moves relative to a base of robot 86 toassist in surgical procedures. See, for example, the surgical robotconfigurations described in U.S. Pat. No. 8,571,638, the contents ofwhich being hereby incorporated by reference herein in its entirety. Insome embodiments, robot 86 is not physically connected with the patientanatomy, for example, a navigation system, as described herein,registers the patient anatomy with respect to the location of robot 86,which includes the location of the robot's end effector 20, such thatrobotic arm 14 extends and moves relative to a base of robot 86 toassist in surgical procedures.

In some embodiments, surgical robotic guidance system 12 includes acontrol unit 87 that matches data from CT scans and C-arm images tolocate surgical robot 86 and allows a surgeon to control surgical robot86, through the use of a mouse, joystick, touch screen, or the like; andmonitor 66. In some embodiments, control unit 87 may include a centralprocessing unit (CPU) and user interface communicating with monitor 66and surgical robot 86. Surgical robot 86 aligns end effector 20 anddrive 18 for alignment with a surgical site requiring a surgicalprocedure percutaneously, mini-open or in open procedures.

In one embodiment, as shown in FIGS. 9-12, spinal implant system 10,similar to the systems and methods described herein, is employed inconnection with one or more surgical procedures, as described herein.Initially, spinal implant system 10 is employed with a method fortreating a spine that includes a preparation and/or a pre-operative step400. Preparation step 400 includes imaging a patient anatomy, forexample, pre-operatively generating three dimensional images of thepatient anatomy. In some embodiments, preparation step 400 includesperforming a three-dimensional scan in an imaging step 410, for example,a CT scan or MRI scan, of the patient anatomy, for example, the spine.In some embodiments, preparation step 400 may include verification ofsurgical instruments, draping and/or camera positioning. In someembodiments, the preparation step includes utilizing O-Arm® imagingdevice 68 in the operating room to obtain the three-dimensional imagesof the patient anatomy intra-operatively and/or prior to surgery 700.

A surgeon reviews three-dimensional scan 410 and formulates and selectsan implant strategy 420 for the components of a spinal construct withthe patient anatomy according to three-dimensional scan 410. In someembodiments, implant strategy 420 includes preparing a pre-operativesurgical plan based on three-dimensional scan 410. In some embodiments,implant strategy 420 includes selecting an insertion path, for example,screw trajectory of screw shaft 22 and positioning of screw shaft 22with the vertebral tissue. In some embodiments, implant strategy 420includes selecting a plurality of screw trajectories for positioning aplurality of screw shafts 22 with vertebrae of the patient anatomy. Insome embodiments, implant strategy 420 employs pre-operative analyticssoftware including anatomy recognition and vertebral segmentationalgorithms for surgical visualization based on a patient's images, forexample as shown in FIGS. 11 and 12, which facilitates formulatingimplant strategy 420 including implant and trajectory placementplanning. In some embodiments, implant strategy 420 may be createdpre-operatively or intra-operatively. Implant strategy 420 includessurgical parameters of trajectory and positioning of one or moreimplants, which are communicated to surgical robotic guidance system 12to direct robot 86 to a location where a surgical procedure is to beperformed to assist in surgical procedures.

In some embodiments, a calibration imaging step 500 includes making anincision in the patient at a site where a connecting member, such as,for example, a clamp or a pin (not shown) of robot 86 is attached to aselected portion of the patient anatomy, such as, for example, vertebrain a step 510. In some embodiments, the clamp is attached with a pelvis,sacrum or ilium of the patient. The clamp is configured to secure robot86 with the patient. The clamp stabilizes robot 86 with the patient toresist and/or prevent relative movement. In some embodiments, the clampincludes an emitter or reflector array to communicate a signal to sensorarray 60. In some embodiments, calibration imaging step 500 includesrobot 86 not being physically connected with the patient anatomy. Forexample, surgical navigation system 16 registers the patient anatomy, asdescribed herein, relative to the location of robot 86, which includesthe location of the robot's end effector 20, such that robotic arm 14extends and moves relative to a base of robot 86 to assist in surgicalprocedures. The patient anatomy and robot 86 may each have referencemarkers, similar to those described herein, which are visible bysurgical navigation system 16. This, in combination with imaging of thepatient anatomy, as described herein and stored with surgical roboticguidance system 12 and/ surgical navigation system 16, enablesregistering the patient's anatomy with respect to location of robot 86.

A calibration step 520 includes attaching a 3D marker 150 and a targetextender 152 with end effector 20 of robot 86, as shown in FIG. 10C. Insome embodiments, robot 86 includes marker 150 and/or extender 152.Robot 86 is calibrated in a step 530 by obtaining imaging of theselected vertebra of the patient on the table in the operating room. Insome embodiments, the images include taking C-arm images of the patientanatomy and these images are calibrated such that a three-dimensionalimage of the selected vertebra is generated. In some embodiments,fluoroscopic images are taken from different angles, such as, 0, 45, and90 degrees. In some embodiments, multiple C-arm images are taken.

During a registration process 600, the three-dimensional scans 410 frompreparation step 400 are transferred in a step 610 to control unit 87.The C-arm images from step 530 are transferred in a step 620 to controlunit 87. A pseudo three-dimensional image of the selected vertebra isgenerated in a robot 86 to patient anatomy registration 630. In someembodiments, registration 630 includes robot 86 not being physicallyconnected with the patient anatomy, as described herein. Thethree-dimensional scan 410 is matched with the multiple C-arm images ina robot 86 to the pre-operative surgical plan registration 630. See, forexample, the registration systems and methods, as described in U.S. Pat.No. 8,571,638, the contents of which being hereby incorporated byreference herein in its entirety. Robot 86 is located adjacent to theselected vertebra in a three-dimensional image and can be manipulated bythe surgeon according to implant strategy 420 for insertion of surgicaltools, medical devices, or implants with a surgical site. Robot 86 canbe controlled from control unit 87 and/or computers 64, 76.

In some embodiments, registration is accomplished by taking windows 90of images of a surgical site, as shown in FIGS. 11 and 12. In someembodiments, windows 90 are selected that specifically relate to theknown location of robot 86. Windows 90 are selected from the C-arm(fluoroscopic) image data. In some embodiments, the same windows arechosen from both the pseudo three-dimensional hybrid C-arm image andfrom the CT image (3D image).

During a surgery 700, surgical robotic guidance system 12 includesintra-operative guidance 710 such that a surgeon directs robot 86, in astep 720, to guide surgical instruments, as described herein, andimplants at a trajectory and position according to implant strategy 420.Robot 86 responds, in a step 725, and moves end effector 20, whichincludes an axial trajectory guide, for example, channel 84 and/or asleeve disposed with surface 82, into position, such that a spinalconstruct component and/or surgical instrument disposed with endeffector 20 can be aligned with a location according to implant strategy420. In some embodiments, the surgeon can insert a spinal constructcomponent and/or surgical instrument with end effector 20 and visuallyverify positioning of the spinal construct component and/or surgicalinstrument from control unit 87 and/or monitor 66. In some embodiments,a surgeon can manipulate robot 86 by use of a joystick, mouse and/ortouch screen.

The components of spinal implant system 10 can be employed with surgery700 for treatment of an applicable condition or injury of an affectedsection of a spinal column and adjacent areas within a body, such as,for example, vertebrae V. To treat a selected section of vertebrae V, amedical practitioner obtains access to a surgical site includingvertebrae V in any appropriate manner, such as through incision andretraction of tissues. In some embodiments, the components of spinalimplant system 10 can be used in any existing surgical method ortechnique including open surgery, mini-open surgery, minimally invasivesurgery and percutaneous surgical implantation, whereby vertebrae V areaccessed through a mini-incision, or sleeve that provides a protectedpassageway to the area. Once access to the surgical site is obtained,the particular surgical procedure can be performed for treating thespine disorder.

Channel 84 of end effector 20 provides an axial guide for spinalconstruct components and/or surgical instruments according to implantstrategy 420 and/or a surgical pathway for delivery of components ofspinal implant system 10, which may include, such as, for example,drivers, extenders, reducers, spreaders, distracters, blades, clamps,forceps, elevators and drills, which may be alternately sized anddimensioned, and arranged as a kit. In some embodiments, the surgeondisposes a sleeve (not shown) with end effector 20, which provides anaxial guide.

For example, implant strategy 420 includes a screw trajectory T1 of aninsertion path and positioning of a screw shaft 22 with a lateral sideof a vertebra V1, as shown in FIG. 13. Screw trajectory T1 includes anaxial or linear pathway for delivering spinal construct componentsand/or surgical instruments to a selected location of the lateral sideof vertebra V1, according to implant strategy 420.

During surgery 700, in a step 730, the surgeon moves arm 14 such thatchannel 84 is aligned with screw trajectory T1. In some embodiments,channel 84 and/or a sleeve, cannula and/or dilator disposed with channel84 defines a surgical pathway along screw trajectory T1 to vertebra V1In some embodiments, surface 82 of end effector 20 may be connected,attached or monolithically formed with a sleeve, cannula and/or dilatorto define the surgical pathway along screw trajectory T1 to vertebra V1.

In a step 740, with channel 84 oriented along screw trajectory T1, thesurgeon positions a cutting instrument (not shown) within the surgicalpathway of channel 84. The cutting instrument is translated by thesurgeon through channel 84 in alignment with screw trajectory T1 andcreates an incision and the surgical pathway through tissue to vertebraV1. The surgeon removes the cutting instrument from channel 84.Alignment of channel 84 with screw trajectory T1 is maintained and thesurgeon positions a drill (not shown) within the surgical pathway ofchannel 84. The drill is translated by the surgeon through the surgicalpathway of channel 84 in alignment with screw trajectory T1. In someembodiments, a cannula or a drill guide is disposed with channel 84 toprotect tissue and facilitate insertion and guidance of the drill. Thedrill is actuated to create a pilot hole in vertebra V1 along screwtrajectory T1. The drill is removed from the surgical pathway of channel84.

In some embodiments, in a step 750, alignment of channel 84 with screwtrajectory T1 is maintained and the surgeon positions a tap instrument200 within the surgical pathway of channel 84. Tap instrument 200, asshown in FIG. 14, forms threads in vertebral tissue about the pilot holeto facilitate fixation and positioning of screw shaft 22 with vertebraV1 along screw trajectory T1 and according to implant strategy 420. Tapinstrument 200 includes a shaft 202 and a handle 204. In someembodiments, tap 200 is configured for connection with an actuator, suchas, for example, a motorized actuator, such as, for example, a powereddrill (not shown). Tap instrument 200 includes a cavity configured forinsertion and internal connection of a threaded tap 206 configured toform an internal or female thread in tissue such that screw shaft 22 canbe threaded into the internal thread formed by tap instrument 200. Tapinstrument 200 is actuated to create threads in vertebral tissue aboutthe pilot hole and removed from the surgical pathway of channel 84. Insome embodiments, a tap instrument 220, as shown in FIG. 15, is employedwith robot 86, similar to tap instrument 200. Tap instrument 220 formsthreads in vertebral tissue about the pilot hole to facilitate fixationand positioning of screw shaft 22 with vertebra V1 along screwtrajectory T1 and according to implant strategy 420. Tap instrument 220includes a shaft 222 and a handle 224. Tap 220 includes tabs 223configured for engagement with recesses of a threaded tap 226 in anexternal connection with threaded tap 226 to form an internal or femalethread in tissue such that screw shaft 222 can be threaded by tapinstrument 220.

In a surgical step 760, alignment of channel 84 with screw trajectory T1is maintained and prior to manipulation of vertebrae V, for example,decompression, disc preparation and/or interbody insertion, screw shafts22 are engaged with vertebrae V. For example, screw shaft 22 isconnected with driver 18, as described herein. The surgeon positionsdriver 18 with screw shaft 22 extending therefrom within the surgicalpathway of channel 84. Driver 18 is translated by the surgeon throughthe surgical pathway of channel 84 in alignment with screw trajectoryT1. Screw shaft 22 engages vertebra V1 and driver 18 is manipulated todrive, torque, insert or otherwise connect screw shaft 22 with the pilothole of vertebra V1 along screw trajectory T1 and according to implantstrategy 420, as shown in FIG. 16. Driver 18 is disengaged from screwshaft 22, as described herein and shown in FIG. 17. Driver 18 is removedfrom the surgical pathway of channel 84.

In some embodiments, implant strategy 420 includes a screw trajectory T2of an insertion path and positioning of a screw shaft 22 with acontra-lateral side of vertebra V1, as shown in FIG, 13, similar toscrew trajectory T1 described herein. Arm 14 is moved to align channel84 with screw trajectory T2 and define a surgical pathway along screwtrajectory T2 to vertebra V1, similar to that described with regard tostep 730. An incision and pilot hole are created in vertebra V1 alongscrew trajectory T2, similar to that described with regard to step 740.In some embodiments, a tap instrument may be used to form threads invertebral tissue about the pilot hole of vertebra V1 along screwtrajectory T2, similar to that described with regard to step 750. Driver18 is connected with screw shaft 22, which engages vertebra V1 alongscrew trajectory T2 and according to implant strategy 420, similar tothat described with regard to step 760.

In some embodiments, implant strategy 420 includes screw trajectoriesT3, T4 of insertion paths and positioning of screw shafts 22 with alateral and contra-lateral side, respectively, of vertebra V2, as shownin FIG. 13, similar to screw trajectories T1, T2 described herein. Arm14 is moved to align channel 84 and define respective surgical pathwaysalong screw trajectories T3, T4 to vertebra V2, similar to thatdescribed with regard to step 730. Incisions and pilot holes are createdin vertebra V2 along screw trajectories T3, T4, similar to thatdescribed with regard to step 740. In some embodiments, a tap instrumentmay be used to form threads in vertebral tissue about the pilot holes ofvertebra V2 along screw trajectories T3, T4, similar to that describedwith regard to step 750. Driver 18 is connected with screw shafts 22,which engage vertebra V2 along screw trajectories T3, T4, respectively,and according to implant strategy 420, similar to that described withregard to step 760. In some embodiments, implant strategy 420 mayinclude one or a plurality of screw insertion paths and/or trajectories.

With one or more screw shafts 22 engaged with vertebrae V, as describedduring surgery 700, vertebrae V is subsequently manipulated in a step770 for selected treatment in connection with a surgical procedure, asdescribed herein. In some embodiments, robot 86 and/or arm 14 can bemoved out alignment with the screw trajectories, or withdrawn from thesurgical site. For example, in a step 800, a decompression instrument,such as, for example, a distractor (not shown) is attached with heads 26of screw shafts 22. The distractor manipulates vertebrae V to rotate,for example, vertebra V2 relative to vertebra V1 to decompressintervertebral space S between vertebrae V, relieve disc pressure,realign one or more vertebra and/or reduce compression on the spinalcord and adjacent nerves.

In some embodiments, manipulation step 770 can include a step 810, whichincludes discectomy performed, for example, between vertebra V1 andvertebra V2 for selected treatment in connection with a surgicalprocedure, as described herein. A discectomy instrument, such as, forexample, a cutter (not shown) is employed to engage tissue betweenvertebra V1 and vertebra V2 at the surgical site. The cutter ismanipulated to disrupt and/or remove tissue to form a cavity invertebral space S, as shown in FIG. 13. In some embodiments, implantstrategy 420 may include surgical parameters for creating a surgicalpathway for discectomy and channel 84 can be employed to facilitatedelivery of the cutter to vertebral space S and discectomy, similar tothat described with regard to surgery 700.

In some embodiments, manipulation step 770 can include a step 820, whichincludes interbody devices (not shown) being implanted with vertebralspace S for selected treatment in connection with a surgical procedure,as described herein. An inserter (not shown) is connected with aninterbody cage for disposal with vertebral space S. In some embodiments,implant strategy 420 may include surgical parameters for creating asurgical pathway for implant of an interbody device and channel 84 canbe employed to facilitate delivery of the interbody device to vertebralspace S for implant, similar to that described with regard to surgery700.

In some embodiments, during surgery 700, in a step 780, a receiver 28 isselected and manipulated for attachment with each screw shaft 22 to formbone fastener 24 having a selected movement, as described herein.Receiver 28 includes ring 44 disposed in channel 46 in a contractedand/or capture orientation having a diameter d1, as shown in FIG. 5. Insome embodiments, receiver 28 is manually engaged with head 26, as shownin FIG. 6, such that ring 44 translates from channel 46 into channel 48over lip 50, as shown in FIG. 7. As head 26 engages ring 44, ring 44expands to an expanded orientation, as shown in FIG. 7, and head 26passes through ring 44. In the expanded orientation, ring 44 expands todiameter d2 (FIG. 5) in channel 48. Diameter d3 of head 26 passesthrough ring 44, as shown in FIG, 8, and the resiliency of ring 44causes ring 44 to contract and translate along the surface of head 26.As ring 44 contracts back to the capture orientation, ring 44 translatesover lip 50 into channel 46, as shown in FIG. 9. Diameter d3 of head 26prevents head 26 from moving through ring 44 when ring 44 returns tochannel 46. In some embodiments, implant strategy 420 may includesurgical parameters for delivery and attachment of receiver 28 employingsurgical robotic guidance system 12 and/surgical navigation system 16.

In some embodiments, during surgery 700, a step 790 includes attachingspinal rods (not shown) with vertebrae V. A rod inserter (not shown) isconnected with a spinal rod. The spinal rod is positioned alongvertebrae V and disposed with cavities 56 of receivers 28 attached withscrew shafts 22 fastened with a lateral side of vertebra V1 and vertebraV2. A second spinal rod is similarly disposed with cavities 56 ofreceivers 28 attached with screw shafts 22 fastened with acontra-lateral side of vertebra V1 and vertebra V2. A rod reducer (notshown) is translated into alignment with the surgical site. The spinalrods are reduced into cavities 56. Set screws (not shown) are deliveredinto engagement with receivers 28. A driver (not shown) is actuated toengage the set screws with receivers 28 to fix the spinal rods withvertebrae V.

Upon completion of a procedure, the surgical instruments andnon-implanted components of spinal implant system 10 are removed and theincision(s) are closed. One or more of the components of spinal implantsystem 10 can be made of radiolucent materials such as polymers.Radiomarkers may be included for identification under x-ray,fluoroscopy, CT or other imaging techniques. In some embodiments, theuse of surgical navigation, microsurgical and image guided technologiesmay be employed to access, view and repair spinal deterioration ordamage, with the aid of spinal implant system 10.

In some embodiments, spinal implant system 10 includes an agent, whichmay be disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the fixation elementswith vertebrae. In some embodiments, the agent may be HA coating. Insome embodiments, the agent may include one or a plurality oftherapeutic agents and/or pharmacological agents for release, includingsustained release, to treat, for example, pain, inflammation anddegeneration.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A method for treating a spine, the methodcomprising the steps of: imaging a patient anatomy; selecting an implantstrategy for at least one bone fastener having a first member;registering the imaging of the patient anatomy with imaging of at leasta portion of a robot; engaging the first member with tissue of thepatient anatomy via robotic guidance according to the implant strategy;and subsequently, manipulating the patient anatomy.
 2. A method asrecited in claim 1, further comprising the step of manually engaging asecond member with the first member to connect the members.
 3. A methodas recited in claim 2, wherein the step of manually engaging the membersincludes snap fitting the first member with the second member in anon-instrumented assembly.
 4. A method as recited in claim 1, whereinthe step of manipulating the patient anatomy includes decompressingvertebrae.
 5. A method as recited in claim 1, wherein the step ofmanipulating the patient anatomy includes discectomy.
 6. A method asrecited in claim 1, further comprising the step of inserting aninterbody implant between a first vertebra and a second vertebra of thepatient anatomy.
 7. A method as recited in claim 1, subsequent to thestep of registering, further comprising the step of drilling a pilothole in the tissue via robotic guidance according to the implantstrategy.
 8. A method as recited in claim 1, subsequent to the step ofregistering, further comprising the step of tapping the tissue viarobotic guidance according to the implant strategy.
 9. A method asrecited in claim 1, wherein the step of imaging a patient anatomyincludes pre-operatively generating three dimensional images of thepatient anatomy.
 10. A method as recited in claim 1, wherein the step ofimaging a patient anatomy includes pre-operatively generating a CT scanof the patient anatomy.
 11. A method as recited in claim 1, wherein thestep of imaging a patient anatomy includes generating a scan with anO-Arm imaging device intra-operatively.
 12. A method as recited in claim1, wherein the step of selecting the implant strategy includespre-operative planning according to the imaging of the patient anatomy.13. A method as recited in claim 1, wherein the at least one bonefastener includes a plurality of pedicle screws and the implant strategyincludes a plurality of screw trajectories for positioning the screwswith a first vertebra and a second vertebra of the patient anatomy. 14.A method as recited in Claim 1, wherein the robot includes an axialtrajectory guide configured for robotic guidance according to theimplant strategy.
 15. A method for treating a spine, the methodcomprising the steps of: pre-operatively generating a CT scan of apatient anatomy including at least one vertebra; selecting an implantstrategy according to the CT scan for at least one bone screw shaft;generating fluoroscopic images of at least a portion of a robot;registering the CT scan with the fluoroscopic images; engaging the bonescrew shaft with the vertebra via robotic guidance according to theimplant strategy; subsequently, manipulating the patient anatomy; andmanually engaging an implant receiver with the bone screw shaft tocomprise a bone screw.
 16. A method as recited in claim 15, wherein thestep of manually engaging includes snap fitting the implant receiverwith the bone screw shaft in a non-instrumented assembly.
 17. A methodas recited in claim 15, subsequent to the step of registering, furthercomprising the step of tapping the vertebra via robotic guidanceaccording to the implant strategy.
 18. A method as recited in claim 15,wherein the step of manipulating includes decompressing vertebrae of thepatient anatomy.
 19. A method for treating a spine, the methodcomprising the steps of: imaging vertebral tissue; selecting an implantstrategy for at least one bone screw shaft; registering the imaging ofthe vertebral tissue with imaging of a robot connected with thevertebral tissue; connecting a surgical driver with the bone screwshaft, the surgical driver including an image guide oriented relative toa sensor to communicate a signal representative of a position of thebone screw shaft; engaging the bone screw shaft with the vertebraltissue via robotic guidance according to the implant strategy;subsequently, manipulating the vertebral tissue; and manually engagingan implant receiver with the bone screw shaft to comprise a bone screw.20. A method as recited in claim 19, wherein the step of manuallyengaging includes snap fitting the implant receiver with the bone screwshaft in a non-instrumented assembly.